John T. Bentivoglio
Health Care Enforcement and Regulation
John Bentivoglio represents pharmaceutical, medical device and biotechnology manufacturers in FDA and health care regulatory issues, compliance programs, and civil and criminal investigations by federal and state law enforcement agencies. He advises clients on federal and state anti-kickback and false claims statutes, FDA advertising and promotional rules, and Medicare and Medicaid regulatory issues. Mr. Bentivoglio has extensive experience developing, implementing and assessing corporate compliance programs in line with the U.S. Sentencing Commission and HHS OIG guidelines, and with state compliance program laws and regulations. In addition, he has assisted pharmaceutical and medical device manufacturers in investigations by various U.S. attorney’s offices, the Criminal and Civil Divisions of the U.S. Department of Justice, and state attorneys general; and negotiated several corporate integrity agreements.
From 1997-2000, he served as associate deputy attorney general and special counsel for health care fraud at the DOJ, where he advised the attorney general and deputy attorney general on national enforcement initiatives, health care investigation and prosecution policies, and interagency coordination. From 1996-1997, he was a special assistant to the assistant attorney general, Criminal Division. Earlier in his career, Mr. Bentivoglio served as a professional staff member to Sen. Joseph R. Biden Jr., chairman, Committee on the Judiciary.
Mr. Bentivoglio repeatedly has been selected for inclusion in Chambers USA: America’s Leading Lawyers for Business and The Best Lawyers in America. He was named a “Life Sciences Star” in Euromoney’s LMG Life Sciences 2012 and 2013, and selected as a member of Law360’s 2012 Life Sciences Editorial Advisory Board.
- “DOJ and OIG Enforcement Update,” Pharmaceutical Compliance Forum, Philadelphia (September 2013);
- “Key Trends in Pharmaceutical & Medical Device Corporate Integrity Agreements,” The Intersecting Worlds of Drug, Device, Biologics and Health Law (FDLI/AHLA Seminar), Washington, D.C. (May 2012);
- “Trends in Pharmaceutical Corporate Integrity Agreements (CIAs): Evolution in Recent CIAs and Likely Future Provisions,” Pharmaceutical Compliance Forum, Cary, N.C. (March 2012);
- “Whistleblower Provisions of Dodd-Frank: Implications for Global Pharma Compliance Programs,” Asian Pharmaceutical Compliance Congress, Singapore (September 2011);
- “Roundtable on Practical Approaches to Anti-Bribery/Anti-Corruption Programs,” International Pharmaceutical Compliance Congress, Istanbul (May 2011);
- “Hot Topics in Biopharmaceutical Compliance” (Moderator), PhRMA Law Section Meeting, Wilmington, Del. (April 2011);
- “Attorney-Client Privilege in the Context of Compliance Work,” AdvaMed Drug and Diagnostic Compliance Group Meeting, Irvine, Calif. (April 2011);
- “Negotiating a Corporate Integrity Agreement: Lessons Learned — and How to Use These Lessons to Strengthen Your Compliance Program,” Pharmaceutical Compliance Forum, Cary, N.C. (March 2011);
- “State Attorney General Investigations of Pharmaceutical Manufacturers,” Pharmaceutical Compliance Congress, Washington, D.C. (October 2011);
- “Health Care Fraud & Abuse: Responding to Emerging Risk Areas,” BNA Audio conference (March 2010);
- “Pharmaceutical and Medical Device Transparency & Disclosure Laws and Initiatives,” Pharmaceutical Compliance Forum, Cary, N.C. (March 2010);
- “How Transparency Will Impact Government Enforcement and Private Litigation,” National Disclosure Summit for Drug, Device and Biotech Manufacturers, Washington, D.C. (March 2010);
- “The Tenth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum” (November 2009);
- “The Fourth Annual Medical Device Regulatory, Reimbursement and Compliance Congress (Device Congress)” (November 2009);
- “Recent Federal and State Settlements Set New Standards for Pharma Commercial, R&D and Compliance Programs,” Pharmaceutical Compliance Congress, Washington, D.C. (October 2008);
- “Pharma in the Crosshairs: What Are the Boundaries for Acceptable Marketing?” FDA/CMS Summit for BioPharma Executives, Washington, D.C. (December 2007);
- Conference co-chair and speaker, “State Ethics and Lobbying Laws for Pharmaceutical Manufacturers,” Pharmaceutical Compliance Congress, Washington, D.C. (November 2007); and
- “Practical Strategies for Managing and Defending a Government Investigation,” Drug and Medical Device Litigation Conference, New York (October 2007).
J.D., Georgetown University Law Center
B.A., University of California, Berkeley
U.S. Department of Justice: Associate Deputy Attorney General (1998-2000); Counsel to the Deputy Attorney General & Special Counsel for Health Care Fraud (1997-1998); Trial Attorney, Criminal Division (1996-1997)
Committee on the Judiciary, U.S. Senate: Professional Staff Member (1988-1992); Legislative Assistant (1986-1988)
“100 Notable People in the Medical Device Industry” Medical Device & Diagnostic Industry (2008)
HHS Office of Inspector General’s Integrity Award (2000)